adecatumumab (MT201) / Amgen - LARVOL DELTA

DEMAND: Monocyte Antigen Carrier Cells for Newly Diagnosed GBM (clinicaltrials.gov) - P1; N=27; Not yet recruiting; Sponsor: Michael Gunn; Trial completion date: Dec 2022 ➔ Mar 2024; Initiation date: Dec 2021 ➔ Mar 2022; Trial primary completion date: Dec 2021 ➔ Dec 2022

Trial completion date • Trial initiation date • Trial primary completion date • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor • GZMB • IFNG • MGMT • MRI

DEMAND: Monocyte Antigen Carrier Cells for Newly Diagnosed GBM (clinicaltrials.gov) - P1; N=27; Not yet recruiting; Sponsor: Michael Gunn; Initiation date: Sep 2021 ➔ Dec 2021

Trial initiation date • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor • GZMB • IFNG • MGMT • MRI

DEMAND: Monocyte Antigen Carrier Cells for Newly Diagnosed GBM (clinicaltrials.gov) - P1; N=27; Not yet recruiting; Sponsor: Michael Gunn

New P1 trial • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor • GZMB • IFNG

[VIRTUAL] Extended Release Octreotide Pharmacokinetics in Healthy Subjects After Subcutaneous Injection of MTD201 (ENDO-I 2020) - "All subjects received Sandostatin® (100μg immediate release; SIR) by deep SC injection 24h before MTD201... MTD201 (30mg) by either IM or SC injection produced continuous octreotide release over a period of at least 63 days at levels predicted to maintain efficacious plasma concentrations at steady state with a dosing interval of up to 8 weeks. Reduced plasma IGF-1 concentrations were maintained throughout the study period. Unlike marketed octreotide depot products, MTD201 can be simply and rapidly reconstituted in WFI to give a stable suspension injectable via 21G needle in a 1.5mL volume."

Clinical • Late-breaking abstract • PK/PD data • Acromegaly • Endocrine Disorders • Neuroendocrine Tumor • Oncology • Pain • Solid Tumor • IGF1

Extended Release Octreotide Pharmacokinetics in Healthy Subjects After Subcutaneous Injection of MTD201 (ENDO 2020) - "MTD201 (30mg) by either IM or SC injection produced continuous octreotide release over a period of at least 63 days at levels predicted to maintain efficacious plasma concentrations at steady state with a dosing interval of up to 8 weeks. Reduced plasma IGF-1 concentrations were maintained throughout the study period. Unlike marketed octreotide depot products, MTD201 can be simply and rapidly reconstituted in WFI to give a stable suspension injectable via 21G needle in a 1.5mL volume."

Clinical • Late-breaking abstract • PK/PD data • IGF1

MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma (clinicaltrials.gov) - P2; N=12; Recruiting; Sponsor: Momotaro-Gene Inc.; Not yet recruiting ➔ Recruiting

Enrollment open

Antibody based EpCAM targeted Therapy of Cancer, Review and update. (PubMed, Curr Cancer Drug Targets) - "The wholly human monoclonal antibody Adecatumumab is dose- and target-dependent in metastatic breast cancer patients expressing EpCAM. The chimeric antibody, Catumaxomab, has been approved for the treatment of malignant ascites; however, this Mab showed considerable results in intrapleural administration in cancer patients. Anti EpCAM toxin conjugated antibodies Oportuzumab Monatox (scFv antibody and Pseudomonas exotoxin A (ETA)) and Citatuzumab Bogatox (Fab fragment with bouganin toxin) and also, immono-conjugate antibody Tucotuzumab (wholly monoclonal antibody with IL2), shown acceptable results in different clinical trials. Almost, all of the antibodies were well- tolerated; however, still more clinical trials are needed for approval of the antibodies for treatment of specific tumors."

Journal

MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma (clinicaltrials.gov) - P2; N=12; Not yet recruiting; Sponsor: Momotaro-Gene Inc.

Clinical • Combination therapy • New P2 trial • PD(L)-1 Biomarker

MTD201 Has a Favourable 28-Day Sustained Release Profile Compared to Sandostatin LAR in Healthy Subjects (ENDO 2019) - "MTD201 uses Q-Sphera™ printing technology to precisely control microparticle size, which facilitates simpler reconstitution and injection using smaller needle size than Sandostatin LAR (SLAR) or Somatuline Autogel. MTD201 produced a safe and effective sustained-release profile of octreotide, supporting a once-monthly treatment interval, as is indicated for SLAR. Therapeutic octreotide concentrations and GH/IGF-1 suppression comparable with SLAR were achieved. Combined with the other advantages for MTD201 regarding smaller needle size, simpler and more reliable reconstitution and injection, these results warrant further study in a suitably powered clinical trial to formally establish MTD201 as an alternative long-acting somatostatin analogue product.*Unless otherwise noted, all abstracts presented at ENDO are embargoed until the date and time of presentation."

Clinical

MTD201 Has a Favourable 28-Day Sustained Release Profile Compared to Sandostatin LAR in Healthy Subjects (ENDO 2019) - "MTD201 uses Q-Sphera™ printing technology to precisely control microparticle size, which facilitates simpler reconstitution and injection using smaller needle size than Sandostatin LAR (SLAR) or Somatuline Autogel. MTD201 produced a safe and effective sustained-release profile of octreotide, supporting a once-monthly treatment interval, as is indicated for SLAR. Therapeutic octreotide concentrations and GH/IGF-1 suppression comparable with SLAR were achieved. Combined with the other advantages for MTD201 regarding smaller needle size, simpler and more reliable reconstitution and injection, these Results warrant further study in a suitably powered clinical trial to formally establish MTD201 as an alternative long-acting somatostatin analogue product."

Clinical

"Midatech Pharma $MTPH FDA feedback on clinical plan for MTD201 https://t.co/afuu52JvXv" (@BiotechRadar)

Clinical